Phase I Study of Single Agent MK-3475 in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma

Trial Information

Phase I Study of Single Agent MK-3475 in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma

Inclusion Criteria

Inclusion criteria

- In Part A: Histological or cytological diagnosis of MEL or any type of carcinoma, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. In Parts B and D of the study, histological or cytological diagnoses of metastatic MEL with progressive locally advanced or metastatic disease. In Parts C and F, histological or cytological diagnosis of NSCLC.

- Failure of established standard medical anti-cancer therapies for a given tumor type or intolerance to such therapy.

- In Parts B, C, D, or F of the study, MEL or NSCLC must be measurable by imaging.

- In Part F of the study, NSCLC with PD-L1 gene expression.

- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

- Adequate organ function.

Exclusion criteria

- Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events caused by therapy administered more than 4 weeks prior to first dose.

- Participation in a study of an investigational agent or using an investigational device within 30 days of administration of lambrolizumab.

- Other form(s) of antineoplastic therapy anticipated during the period of the study.

- History of pneumonitis or interstitial lung disease.

- Medical condition that requires chronic systemic steroid therapy, or on any other form of immunosuppressive medication.

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